The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Cas Knee Instrumentation.
| Device ID | K043223 |
| 510k Number | K043223 |
| Device Name: | DEPUY CAS KNEE INSTRUMENTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Randa Franklin |
| Correspondent | Randa Franklin DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2005-03-04 |
| Summary: | summary |